UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004826 |
|---|---|
| Receipt number | R000005717 |
| Scientific Title | Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer |
| Date of disclosure of the study information | 2011/01/06 |
| Last modified on | 2015/01/13 10:41:23 |
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Basic information
Public title
Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer
Acronym
Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer
Scientific Title
Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer
Scientific Title:Acronym
Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the antiemetic efficacy and safety of Palonosetron and Granisetron in combination with Dexamethasone and Aprepitant in patients receiving Cisplatin containing chemotherapy for head and neck cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
the proportion of patients with a Complete Protection during the overall phase(0-120 h postchemotherapy), the proportion of patients with a Complete Response during the overall phase
Key secondary outcomes
1)the proportion of patients with a Complete Protection during
the acute phase (0-24 h postchemotherapy) and the delayed
phase (24-120 h postchemotherapy)
2)the proportion of patients with a Complete Response during the overall phase and the acute phase and the delayed phase
3)the proportion of patients with a Complete Control during the overall phase and the acute phase and the delayed phase
4)the proportion of patients without nausea
5)the proportion of patients without emesis
6)time to treatment failure
7)safety
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aprepitant is administered orally at 125 mg/body 1 hour or 1 hour and half before Cisplatin administration. On day 2 and 3, Aprepitant is administrated orally at 80 mg/body.
Granisetron 40 ug/body and Dexamethasone 12.3 mg/body are
administered intravenously 30 min before Cisplatin administration. On day 2 and 3, Granisetron 40 ug/body and Dexamethasone 6.6 mg/body are administrated.
Interventions/Control_2
Aprepitant is administered orally at 125 mg/body 1 hour or 1 hour and half before Cisplatin administration. On day 2 and 3, Aprepitant is administrated orally at 80 mg/body.
Palonosetron 0.75 mg/body and Dexamethasone 12.3 mg/body are
administered intravenously 30 min before Cisplatin administration. On day 2 and 3, Dexamethasone 6.6 mg/body are administrated.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) histologically or cytologically confirmed head and neck cancer
2) stage III-IV head and neck cancer
3) without prior treatment
4) age: >=20 and <75
5) patients who are scheduled to receive high emetogenic chemotherapy (Cisplatin >=60 mg/m2)
6) sufficient function of important organs
a)WBC: >=3,000/mm3
b)AST: <100 IU/L
c)ALT: <100 IU.L
d)Ccr: >=60 ml/min/body
7) Performance Statues: 0-1(ECOG)
8) written informed consent
Key exclusion criteria
1) with seizure disorder needing anticonvulsants unless clinically stable
2) with vomiting, retching, or grade 2 or higher nausea according to
CTCAE
3) with QTc prolongation by electrocardiography (QTc: >470 msec)
4) with severe allergy to Palonosetron, Granisetron, Aprepitant and Dexamethasone
5) pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant
6) receiving an antiemetic drug
7) receiving pimozide (orap)
8) with history of mental disorder or treating it at the moment
9) doctor's decision not to be registered to this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiko Oridate |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Biology and Function in the Head and Neck
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL
045-787-2687
noridate@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiko Oridate |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Biology and Function in the Head and Neck
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL
045-787-2687
Homepage URL
noridate@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜市立大学附属病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2010 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 06 | Day |
Last modified on
| 2015 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005717
